Yale Breast Cancer Drug Gets FDA Approval After 25 Years

After 25 years of turning a bold scientific idea into reality, Yale chemist Craig Crews just saw his pioneering cancer therapy receive FDA approval, opening new doors for breast cancer patients nationwide.

The drug, called vepdegestrant and sold under the brand name Veppanu, works differently than traditional cancer treatments. Instead of blocking harmful proteins, it actually degrades them, eliminating the root cause of certain breast cancers at the cellular level.

This matters because breast cancer is the most common cancer among women worldwide, with many tumors driven by estrogen receptor signaling. The new once-daily oral therapy specifically targets adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, a particularly challenging form of the disease.

Crews first asked himself a simple question decades ago: "Could we find a way to drag problem proteins to the natural machinery responsible for recycling proteins inside of cells?" That curiosity led to the development of PROTACs (PROteolysis TArgeting Chimera), a completely new class of drugs that work with the body's existing systems.

The approval carries personal meaning for Crews, who is the John C. Malone Professor of Molecular, Cellular, and Developmental Biology at Yale. His mother was diagnosed with breast cancer last year, giving him firsthand insight into the challenges patients and families face when considering treatment options.

Crews founded the biotechnology company Arvinas in New Haven over a decade ago based on his PROTAC research. The company partnered with Pfizer to develop vepdegestrant, which became the first PROTAC therapy to receive FDA approval last week.

The Ripple Effect

The approval of vepdegestrant opens doors far beyond breast cancer treatment. Dozens of companies inspired by Yale's PROTAC research are now developing degrader therapies for numerous cancer types, and researchers believe the approach could tackle neurodegeneration and other challenging diseases.

Crews has successfully bridged academia and biotech throughout his career, launching several drug development companies including Halda Therapeutics, recently acquired by Johnson & Johnson for its novel prostate cancer therapy. His earlier work on protein degradation led to Kyprolis, an FDA-approved drug for treating multiple myeloma.

The journey from lab concept to FDA approval demonstrates why supporting basic research matters. Most exciting new drugs developed today stand on the foundation of curiosity-driven science that asks simple questions and pursues answers wherever they lead.

Thousands of breast cancer patients now have an additional treatment option, thanks to one scientist who wondered if cells could clean up their own problems.